Vivitrol® Program

VIVITROL® is a non-addictive, once-a-month injection prescription treatment clinically shown to prevent relapse in alcohol and opioid-dependent patients when used in combination with an IOP counseling program. It is only administered after opioid or alcohol detoxification.

Before taking VIVITROL®, it is imperative that you stop taking opioids or drinking alcohol. VIVITROL® may not work for everyone and has not been proven safe or effective in children.

VIVITROL® can cause serious side-effects, including:

• Risk of an opioid overdose – Because VIVITROL® blocks the effects of heroin and other opioid pain medications, there is an increased risk of injury, coma, or death if you continue taking them while receiving VIVITROL®, especially in large amounts.
• Severe reactions at the site of injection – Some individuals who have been prescribed VIVITROL® have had severe injection-site reactions, including tissue death. VIVITROL® must be injected by a healthcare provider. Call your doctor or healthcare provider immediately if you experience any of the following symptoms at the site of injection:
  • Severe pain
  • The injection site feels hard
  • Swelling
  • Lumps or blisters
  • An open sore or wound
• Sudden opioid withdrawal – To avoid sudden withdrawal from opioids, you have to stop taking all forms of opioids, including street-drugs; prescription pain medicines, cold or flu medications containing opioids, and opioid dependence treatment including methadone and buprenorphine, for a minimum of 7 to 14 days before starting VIVITROL®.
• Liver damage or hepatitis – The active ingredient in VIVITROL®, Naltrexone, has been shown to cause liver damage or hepatitis. Tell your healthcare provider immediately if you experience any of the following during your treatments:
  • Intense stomach pain
  • Dark yellow-brown urine
  • Jaundice, or yellowing of the eyes
  • The feeling of overwhelming sleepiness

Your doctor may stop your VIVITROL® treatments if you get any signs or symptoms of a serious liver issue.

Do not take VIVITROL® if:

• You have a physical dependence on opioids, opioid street-drugs like heroin, or opioid-containing medications BEFORE you’ve consulted with your doctor or healthcare provider. They may want to administer the naloxone challenge test to see if you are able to take VIVITROL®.
• You are experiencing opioid withdrawal symptoms such as:
  • Sleeplessness
  • Anxiety
  • Yawning
  • Fever
  • Painful Muscles
  • Cramps
  • Sweating
  • Watery Eyes
  • Constant Cold Chills
  • Shakiness
  • Diarrhea
  • Nausea & Vomiting

You are allergic to naltrexone or any of the ingredients in VIVITROL®.

Before you take VIVITROL®, tell your doctor if:

• You have liver problems
• You use or abuse opioids
• You have a bleeding disorder, like hemophilia
• You have kidney problems
• You have any chronic medical condition

Tell your doctor or healthcare provider about all the medications you take, including prescriptions, over-the-counter, supplements, vitamins, and illegal drugs.

VIVITROL® is injected by a doctor or healthcare provider, once a month. DO NOT attempt to give yourself VIVITROL® as serious allergic reactions that may require hospitalization can occur.

VIVITROL® is given in the muscles of the buttocks using a small needle. Once it is administered, it cannot be removed and will last for a month.

If you miss an appointment for your VIVITROL® injection, make a new appointment as soon as possible. The medication is more effective when it’s given continuously.

You should not drive a car or operate heavy machinery until you know how VIVITROL® affects you. It may make you feel sleepy or dizzy.

VIVITROL® can cause a number of side-effects, including:

• Depressed mood – This can sometimes lead to negative or suicidal thoughts. Make sure to tell the people closest to you that you are taking VIVITROL®.
• Pneumonia – Certain people taking VIVITROL® have developed a certain strain of pneumonia that is caused by an allergic reaction to the medication.
• Serious allergic reactions – Skin blistering or rash, swelling of your tongue, eyes, or face, difficulty breathing, chest pain, and dizziness.
• Other common side effects – Nausea (This usually improves after your first VIVITROL® injection and is less-likely with future injections), tiredness, headaches, vomiting, muscle pain, decreased appetite, and cold symptoms.

Tell your doctor or healthcare provider if you have any symptoms that are bothering you or if you have any side-effects that do not get better while taking VIVITROL®.

Active ingredient: Naltrexone

Inactive ingredients: Polylactide-co-glycolide (PLG)

Diluent ingredients: Carboxymethylcellulose sodium salt, polysorbate 20, sodium chloride, and water for injection